Randox Laboratories Ltd.: Medical Device Recall in 2022 - (Recall #: Z-1097-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

CK MB Calibrator, Catalogue Number CK2393

Product Classification:

Class III

Date Initiated: March 25, 2022

Date Posted: May 25, 2022

Recall Number: Z-1097-2022

Event ID: 90046

Reason for Recall:

Randox have realigned CK-MB Calibrator, CK2393, lot number 4410CK. Calibrating with the new value will cause a positive shift of approximately 6% with both Quality Controls and Patient Samples.

Status: Terminated

Product Quantity: 1,392

Code Information:

GTIN 05055273201451 Lot 4410CK

Distribution Pattern:

Domestic distribution to WV and PR. International distribution to Bangladesh, Bosnia & Herzegovina, Botswana, China, Colombia, Costa Rica, Croatia, Egypt, Fiji, France, Georgia, Germany, Ghana, Greece, Grenada, Hong Kong, India, Iraq, Italy, Lithuania, Malaysia, Maldives, Malta, Mexico, Morocco, Mozambique, Nepal, Nigeria, Pakistan, Philippines, Poland, Puerto Rico, Romania, Russia, Saudi Arabia, South Korea, Switzerland, Thailand, Turkey, UK, Uruguay, Uzbekistan and Vietnam.

Voluntary or Mandated:

Voluntary: Firm initiated